Community Dent Oral Epidemiol 2012; 40: 116124 All rights reserved

2011 John Wiley & Sons A/S

Reassessment at 67 years of age of a randomized controlled trial initiated before birth to prevent early childhood caries
Plutzer K, Spencer AJ, Keirse MJNC. Reassessment at 67 years of age of a randomized controlled trial initiated before birth to prevent early childhood caries. Community Dent Oral Epidemiol 2012; 40: 116124. 2011 John Wiley & Sons A S Abstract Objective: To assess whether the effect of providing mothers with guidance during pregnancy and when the child was 6 and 12 months old, which had drastically reduced the prevalence of early childhood caries at 20 months of age, would be sustained at 67 years of age. Methods: Children, whose mothers had been enrolled in a randomized controlled trial during pregnancy and a comparison group of similar school children, were examined for the presence of caries by the South Australian School Dental Services (SA SDS) at 67 years of age. Results: Of 625 eligible trial participants, 277 (44%) participated in the follow-up and dental records were available for 187 of them (30%). Loss to follow-up and reasons for it were similar in the intervention and control groups. At 67 years of age, 33% of children in the trial had caries compared with 42% in the SA SDS comparison group (n = 263). All measures of caries severity (d3mft, d3mfs and SiC30) were lower, but not signicantly so, in the intervention than in the control group. Children in the comparison group of school children had more severe caries than those in the trial (P < 0.01) and in the intervention group especially (P < 0.005). Children in both randomized groups suffered signicantly less toothache than those in the comparison group (P < 0.001). Conclusion: Providing new mothers with guidance on caries prevention helps to reduce early childhood caries and has a sustainable effect up to school age.

Kamila Plutzer1, A. John Spencer1 and Marc J. N. C. Keirse2

Australian Research Centre for Population Oral Health, School of Dentistry, The University of Adelaide, 2Department of Obstetrics, Gynaecology and Reproductive Medicine, Flinders University, Adelaide, South Australia, Australia
1

Key words: anticipatory guidance; early childhood caries; follow-up study; health promotion; primary prevention; randomized controlled trial Kamila Plutzer, Australian Research Centre for Population Oral Health, School of Dentistry, The University of Adelaide, SA 5005, Australia Tel.: +61 88303 3292 Fax: +61 88303 4858 e-mail: kamila.plutzer@adelaide.edu.au Submitted 10 March 2011; accepted 12 September 2011

Early childhood caries (ECC) is an infectious and communicable disease that originates from an interaction among several biological, behavioural and social determinants. It is dened as one or more decayed (cavitated or noncavitated), missing because of caries, or lled primary tooth in a child under 6 years of age (1). In children younger than 3 years of age, any sign of smooth surface caries (cavitated or noncavitated) is considered to be severe ECC (S-ECC). From the 1970s to the 1990s, the prevalence of caries in young children declined in most developed countries (2), but this decline has not been sustained. A recent review of epidemiological data, available since 2000 in a variety of low-, middle- and high-

income countries, indicated a marked increase in the prevalence of caries in both the deciduous and permanent dentitions of young children (3). In 2006, for example, the prevalence of caries among 6-yearold children ranged between 89% and 97% in countries, such as Mexico, the Philippines and Taiwan (35). In the United Kingdom, there was no decline in the proportion of 5-year olds with obvious caries in their primary teeth between the national surveys of 1993 and 2003 (3). Norway saw an increase in caries of 3.3% per year in the permanent teeth of 12-year olds between 2000 and 2004 in contrast to the yearly decline of 3% noted before 2000 (6). In Australia, the mean dmft (the sum of decayed, missing because of caries and lled teeth) at 4 years
doi: 10.1111/j.1600-0528.2011.00643.x

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of age (the youngest group for which oral health data are routinely collected) increased from 1.10 in 1997 to 1.70 in 2004. In 2004, 38% of 4-year-old children had a dmft > 0 (7). Early childhood caries adversely affects all aspects of a childs quality of life and well-being and also impacts on the quality of life of its parents (8). Nowadays, ECC is the main reason for hospitalization of children aged 4 years or less in Australia (9) As a result, ECC has become a signicant public health problem as it has across the world (3, 10). Not to be ignored either is the psychological impact on children and their parents and the nancial burdens for families and communities. No single factor has been identied as responsible for the increased prevalence of ECC, and various preventive programmes have met with variable degrees of success (1113). However, well-informed parents can help reduce ECC by taking a pro-active approach to their childrens oral health (1417). We conducted such a programme in a randomized controlled trial, targeting mothers expecting their rst child (18). The intervention resulted in a more than 5-fold difference in S-ECC between the intervention and the control groups (1.7% versus 9.6%; P < 0.001) at 20 2.5 (SD) months of age (18). As most of the decay was demineralization of incisors, it remained unanswered whether the intervention also reduces rates of cavitated lesions, which more seriously affect quality of life (8). Equally unanswered was whether the intervention would have benets for teeth that erupt later in childhood. As caries in the primary dentition often leads to caries in the permanent dentition (1921) with life-long consequences, there was an obvious need to study the long-term effects of the intervention. The current study examines the outcomes of that intervention up to 7 years of age and compares the caries experience of these children with that observed in a similar group of children, enrolled with the South Australian School Dental Services (SA SDS).

Materials and methods

Randomized study group
Participants in the randomized trial (n = 649) were recruited in 2002 in an oral health promotion intervention programme Cavity free children to decrease the incidence of S-ECC. Details and outcomes of the trial at 20 months of age were published previously (18). Women expecting their rst child

were enrolled with ethical approval and signed informed consent at all ve public maternity hospitals in Adelaide, South Australia, during regular antenatal visits. Women in the intervention group received a series of three rounds of printed information on oral health maintenance, emphasizing the importance of mothers practices and the specic health needs of their child at that particular stage of its development (obtainable from the authors). The rst round, focusing on mothers oral health, was provided at enrolment in the study, the second when the child was 6 months old, and the third when the child was 12 months old. The latest two sets were mailed to the home address. There was no interaction with the control group between enrolment and the outcome assessment at 20 months. After the primary outcome assessment, at 20 months of age, attempts were made to retain all 649 participants enrolled during pregnancy, except 24 who were excluded for lack of a motherinfant pair (18). Sample maintenance began in 2005 (Fig. 1). It involved a series of cards and messages related to childrens oral health. Thus, in 2006, all mothers from both groups received a motivational letter and a fridge calendar, emphasizing the importance of good oral health and hygiene. In 2007, the message was reinforced with a specially designed New Years card and, in 2008, with a fridge miniposter Keeping teeth healthy for life. Whenever mail was returned undelivered, a missing participant search was started through available contact addresses and phone numbers, phone books, the electoral ofce and the hospital of birth. In 20082009, a series of approaches (22) were used to contact all 625 still eligible participants enrolled during pregnancy. An invitation letter explaining the follow-up was mailed. This was followed by further information, a Child Oral Health Survey questionnaire, and a request for consent to access the childs record at the South Australian School Dental Services (SA SDS). Two weeks after the rst mail-out, a reminder letter was sent to nonresponders, followed 2 weeks later by a further letter including all items sent earlier. Thereafter, nonresponders were contacted by phone and further material was sent, if a phone contact was established.

South Australian School Dental Services (SA SDS) comparison group

About 80% of parents enrol their child with SA SDS at the time of school entry. The dentists and dental

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2002 Nulliparous women approached in pregnancy (n = 814)

Excluded (n = 21) Refusals (n = 144)

Randomisation (n = 649) and baseline data collection Intervention group (n = 327) interventions in pregnancy at 6 months at 12 months Control group (n = 322) no contact

2004 Initial outcome assessment at 20 months Assessed (n = 232) Excluded (n = 15) Lost (n = 80) Assessed ( n = 209) Excluded (n = 9) Lost (n = 104)

oral hygiene; general health; social support; and demographic characteristics. Not all data were analysed for this study. Demographic characteristics were used to test the comparability of the groups. Mothers reports on oral health information, received from health care practitioners, were analysed for differences between those in the intervention and in the control or comparison groups. We also compared toothache experience in the two randomized groups and the comparison group as a further potential indicator of caries outcomes.

2005 Sample maintenance started for participants with mother-infant pair (n = 625) 2008 Approached for long-term follow-up (n = 312) (n = 313) Comparison group of children born in 2002 from SA SDS Approached (n = 641) Excluded (n = 49) 2009 Completed Child Oral Health Survey questionnaire received (n = 141) 2010 (n = 136) (n = 277)

Dental examinations
Dental examinations for both randomized groups and the SA SDS comparison group were conducted by SA SDS practitioners, who had been trained and calibrated. While all children in the comparison group were enrolled with SA SDS, this was not so for all children in the trial, whose families may have opted for private dental care. However, trial participants were encouraged to have a follow-up examination by SA SDS staff, arranged by the research team. The results of the most recent dental examinations, conducted as the last in 2008 or the rst in 2009, when children were 6 to 7 years old, were retrieved from the SA SDS database for all children. For the randomized children, we retrieved the most recent examination conducted after the age of 6, irrespective of when it had been done. To avoid variation in assessment, we did not consider dental examinations conducted by private practitioners, as these were not calibrated. For the same reason and to concentrate on substantive outcomes, we disregarded noncavitated (enamel) lesions, considering only dentine lesions (i.e. d3 lesions) as unequivocal evidence of decay.

Dental records of SA School Dental Services retrieved (n = 96) (n = 91) (n = 262)

Fig. 1. Flow diagram of the participants in the randomized controlled trial and in the comparison group from rst contact until follow-up.

therapists of SA SDS provide a range of dental services at clinics throughout Adelaide and all major South Australian regional centres. All children from birth up to 18 years of age are eligible for care. Children whose parents hold social security cards receive free care. A co-payment (AU $ 36 per year) applies to other children entitling them to receive general dental care, including restoration, radiography and preventive services, such as cleaning and uoride applications, without further cost. A comparison group of 641 children, born as the rst child in a family in 2002, without congenital or developmental defects and with the same postcode distribution as the children in the trial, was derived from the SA SDS database by an independent person not involved in the study. Mothers of these children were sent a letter of invitation followed by the same questionnaire and consent form as mothers in the trial. Nonresponders received two reminders at 2-week intervals.

Data analysis
All dmft and dmfs (decayed, missing because of caries or lled teeth or surfaces) analysed relate to d3mft and d3mfs (i.e. dentine lesions) excluding noncavitated (enamel) lesions. We also calculated a caries severity index, SiC30, dened as the mean dmft among the 30% of children with the highest caries score (23). PASW Statistics 18 was used for statistical analyses, including chi-square tests and logistic regression for binary outcome data, and t-tests for equality of means for continuous data.

Questionnaire survey
The Child Oral Health Survey questionnaire, completed by mothers in the privacy of their home, consisted of six sections: dental problems and use of dental services for their child; feeding practices;

Ethical considerations
Initial approval was obtained from the ethics committees at all ve hospitals where women were

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recruited (18). Further approval for the follow-up was obtained from the Human Research Ethics Committee at the University of Adelaide and the Board of the SA SDS. Mothers signed informed consent to participate and to access SA SDS records.

tically signicant differences between the randomized groups and the comparison group. However, because of the tighter time period for dental examinations in the comparison group than in the randomized groups, children in the trial were on average 6.5 months older at examination than those in the comparison group (Table 3).

Results
Response rate
Figure 1 shows the ow of trial participants from the time of enrolment in 2002 until 2010, as well as the construction of the comparison group. Whereas loss to follow-up at 20 months had been signicantly greater in the control group, without contact for about 2 years, efforts to maintain contact thereafter redressed that imbalance. Questionnaires and consent were received from 277 mothers originally enrolled (response rate: 44.3% calculated from baseline and 62.8% calculated from children examined at 20 months). However, no recent records were available in the SA SDS database for 32% of these children, with no difference between the intervention and control groups (Fig. 1). The reasons were also similar: mainly families with private insurance (28 in each group) and, therefore, presumably seeking dental care from private dentists or having moved from the area (intervention: 12; control: 10). Of 641 families approached in the comparison group, 49 were excluded because of undeliverable mail, language issues, or child living abroad or with foster parents. Completed questionnaires were obtained from 277 (response rate: 46.8%), but 15 had no signed consent to retrieve dental records (Fig. 1).

Caries on dental examination

Table 3 compares the prevalence of caries (i.e. the percentage with d3mft > 0, not including noncavitated lesions) in the two randomized groups and the comparison group. The proportion of children with caries did not differ signicantly among groups. In the randomized trial, there was a statistically nonsignicant trend for lower d3mft and d3mfs values in the intervention group than in the control group. There were no statistical differences between the randomized control group and the nonrandomized comparison group. However, the mean d3mft and d3mfs were signicantly lower in the intervention group than in the SA SDS comparison group. The same applied, to a lesser extent, when the comparison group was compared to the entire randomized cohort (Table 3). There was no signicant difference in the caries severity index, SiC30, between the intervention and control groups. Yet, children in the trial and those in the intervention group in particular had lower SiC30 values than the comparison group (P < 0.001; Table 3). Caries prevalence increased with 3.1% for each additional month of a childs age (95% condence interval: 1.1%5.1%; P < 0.001). Logistic regression analysis, adjusted for differences in age (Table 3), showed a lower caries prevalence in the trial cohort than in the SA SDS cohort (odds ratio: 0.71; 95% condence interval: 0.570.88; P < 0.005). The same applied when further adjustment was made for family structure (single or two-parent family) and socioeconomic status. It also applied to separate analyses between the intervention and comparison groups and between the control and comparison groups, all with similar odds ratios and levels of statistical signicance (data not shown). However, none of the adjusted logistic regression analyses showed a signicant difference between the intervention and control groups; all produced odds ratios with wide condence intervals crossing unity.

Characteristics of participating mothers and children

Characteristics of the intervention and control groups in the trial, at enrolment and at follow-up, are shown in Table 1. It indicates that the two groups, comparable at the time of randomization, had remained comparable at follow-up. Loss to follow-up was more frequent when mothers were younger, were separated or single, had lower levels of education, had lower income, or did not have private dental insurance. This applied equally to both arms of the trial. Table 2 provides demographic characteristics for the comparison group in relation to the two randomized groups, based on data from the 2009 Child Oral Health Survey. There were no statis-

Dental health issues reported by mothers

Twenty-nine per cent of mothers in the comparison group reported that their child had suffered tooth-

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Plutzer et al. Table 1. Characteristics at enrolment of mothers randomized during pregnancy and retained in the study at follow-upa Mothers at enrolment (2002) Intervention Baseline characteristic Total number Country of birth Australia Other Not disclosed Maternal age at childbirth 1419 years 2034 years 3545 years Marital status Married De facto Separated Single Not disclosed Highest completed education Primary Secondary Tertiary Not disclosed Family income (Au $) <20 000 20 00140 000 40 00160 000 >60 000 Not disclosed Concession card holder Yes No Not disclosed Private dental insurance Yes No Not disclosed
a

Retained in follow-up (2009) Intervention n % Control n %

Retention rate (%)

Control n %

Intervention

Control 42.2 41.5 43.9 27.1 45.4 47.8 51.5 39.8 28.6 29.9 25.2 55.4 55.6 26.6 41.5 59.1 60.6 43.9 38.7 86.0 32.6

Total 42.7 41.2 49.1 21.7 46.2 57.8 55.9 34.7 28.6 28.8 29.3 49.0 58.3 26.9 40.3 57.3 63.2 45.1 39.8 87.6 32.1

327 322 141 136 43.1 Birth country-related difference in retention: not signicant (P = 0.15) 264 82.7 258 81.9 108 78.3 107 81.1 40.9 55 17.3 57 18.1 30 21.7 25 18.9 54.5 8 7 3 4 Age-related difference in retention: P < 0.001 56 17.1 59 18.3 9 6.4 16 11.8 16.1 249 76.1 240 74.5 117 83.0 109 80.1 47.0 22 6.7 23 7.1 15 10.6 11 8.1 68.2 Marital status-related difference in retention: P < 0.001 149 47.2 130 41.7 89 65.0 67 51.1 59.7 98 31.0 98 31.4 29 21.2 39 29.8 29.6 7 2.2 7 2.2 2 1.5 2 1.5 28.6 62 19.6 77 24.7 17 12.4 23 17.6 27.4 11 10 4 5 Education-related difference in retention: P < 0.001 120 37.7 119 39.3 40 29.0 30 22.7 33.3 122 38.4 121 39.9 52 37.7 67 50.8 42.6 76 23.9 63 20.8 46 33.3 35 26.5 60.5 9 9 3 4 Income-related difference in retention: P < 0.001 81 28.3 79 28.8 22 17.9 21 18.1 27.2 103 36.0 118 43.1 40 32.5 49 42.2 38.8 59 20.6 44 16.1 33 26.8 26 22.4 55.9 43 15.0 33 12.0 28 22.8 20 17.2 65.1 41 48 18 20 Concession-related difference in retention: not signicant (P = 0.23) 99 30.9 114 36.4 46 33.8 50 39.4 46.5 221 64.1 199 63.6 90 66.2 77 60.6 40.7 8 8 5 7 Insurance-related difference in retention: P < 0.001 63 19.7 50 15.9 56 40.9 43 33.3 88.9 257 80.3 264 84.1 81 59.1 86 66.7 31.5 8 7 4 7

All percentages are valid percentages excluding missing values.

ache, compared with only 11% in the intervention group (P < 0.001) and 17% in the control group (P < 0.001). More mothers in the control group than in the intervention group had relied on professional advice on oral health maintenance for their child, beyond that provided within the trial (86.6% versus 73.5%; P < 0.05).

at the examination. While this seems to testify to the benet of our intervention study, the difference in caries experience between those receiving and not receiving the intervention, which had been large at 20 months of age (1.7% versus 9.6%; P < 0.001) (18), had lost its statistical signicance by 6 to 7 years of age. Several limitations need to be considered, though, when interpreting these ndings.

Loss to follow-up

Discussion
The main ndings of our study are that children, enrolled in the randomized trial before birth, had suffered less toothache and exhibited less caries than other school children, despite being half a year older

Assessing the long-term effect of preventive interventions is fraught with difculties as people, not dependent on ongoing care, lose interest, pursue other goals in life, or become lost for one reason or another (24). Studying the effect of an intervention, initiated before birth, for up to 7 years after birth

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Reassessment at 67 years of age of a randomized controlled trial Table 2. Comparison of the characteristics of children in the randomized trial and in the SA SDS comparison group Randomized group (n = 277)a Intervention Characteristic n Control n 35 69 24 8 16 73 37 10 28 44 5 52 7 10 62 42 15 7 50 7 43 7 Total n 72 138 55 12 39 140 82 16 52 102 8 101 14 21 120 91 32 13 96 12 99 11 % 27.2 52.1 20.8 14.9 53.6 31.4 19.9 38.8 3.0 38.4 8.0 45.4 34.4 12.1 36.2 37.2 n 73 138 47 9 42 156 87 12 56 109 10 93 9 21 64 91 28 17 109 8 122 8 % 27.2 51.5 21.3 15.8 51.3 32.8 20.9 40.7 3.7 34.7 8.1 47.3 33.8 10.8 40.5 45.4 Comparison groupa (n = 277)

Number of siblings None 37 One 69 Two or more 31 Not disclosed 4 Mothers highest completed education Primary 23 Secondary 67 Tertiary 45 Not disclosed 6 Mothers occupational status Full-time employed 24 Part-time employed 58 Full-time student 3 Full-time mother 49 Not disclosed 7 Household income in Au $ <20 000 11 20 00160 000 58 60 001100 000 49 >100 000 17 Not disclosed 6 Concession card holder 46 Not disclosed 5 Private dental insurance 56 Not disclosed 4

a All percentages are valid percentages excluding missing values. None of the differences between the study and comparison groups are statistically signicant.

might well qualify as the most troublesome of such endeavours. After all, the main strength of a randomized controlled trial, after concealed and unbiased allocation, is in the assessment of all people as randomized (25, 26). Yet, young families are known to exhibit a great deal of residential mobility, to acquire a second or third child within 7 years and to have more pressing priorities than to continue participation in a trial that does not offer them or their child any further direct benets. A retention rate of 44% from enrolment to outcome assessment may be regarded as disappointing from a trial methodology point of view (24, 26). However, there are considerable difculties in keeping track of healthy rst-born children from before birth up to 7 years of age. In our study, we tried to recruit everyone originally enrolled, irrespective of what had happened afterwards. We also tried to keep track of the characteristics of mothers and children lost to follow-up. These characteristics predictable from other longitudinal studies (27) were as follows:

teenage mothers, single mothers, low education and poor socioeconomic status. However, we found no evidence that these factors differed between the two randomized groups. Characteristics of those lost to follow-up were also similar to those that accounted for nonresponders in the SA SDS comparison group.

Random error and systematic error

A further limitation is that, contrary to the assessment at 20 months of age (18), which was conducted by a single dentist, we relied on records held by SA SDS. SA SDS practitioners were not specically trained and calibrated before these examinations, but they were unaware of what group each child belonged to. Also, because comparison children were recruited from the same postal districts as children in the trial, differences among groups would not be affected by differences in the assessment from one location to another. A systematic error (i.e. bias) may have occurred, though, because 32% of children in the trial had no

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Statistical difference (P value)a

Intervention versus comparison

<0.001 ns

<0.005 <0.001 <0.01 <0.001 <0.001

relevant records with SA SDS, predominately because their family had private dental insurance. It could be argued that we should have sought funds for all trial participants to be assessed by SA SDS. Reasonable as the argument is, it would have introduced a different bias, when examiners became aware of which group each child belonged to.

Study versus comparison

<0.001 ns

<0.01 <0.01 ns <0.05 <0.001

Contamination bias
Contamination bias undoubtedly affected the loss of statistical signicance between intervention and control groups at follow-up, compared with the difference (1.7% versus 9.6%) earlier on (18). At the examination at 20 months, there had been no contact with the control group since randomization. However, at that examination, all mothers received detailed guidance on caries prevention in accordance with good clinical practice. Thereafter and to retain the randomized participants, both groups received the same additional health promotion material by mail. Both the initial examination at 20 months and the later mail to the trial participants reduced the difference between intervention and control. Mothers in the control group, sensitized to the prevention of ECC, had an opportunity to catch up with what mothers in the intervention group had received already. We could have reduced contamination bias by giving no information at the dental examination at 20 months of age and by replacing health promotion mail-outs by Christmas and birthday cards, but decided against it. Even so, mothers in the control group still reported more oral health advice from health care professionals than mothers in the intervention group. This too may have reduced the difference between the intervention and control group, compared with the examination at 20 months of age (18). Nonetheless, as noted by others (28), it also emphasizes the importance of sensitizing parents to the prevention of ECC.
ns, not statistically signicant.

Intervention versus control

ns ns

Table 3. Results of the dental examinations of children in the study group as randomized and in the comparison group

Comparison group

Total

Randomized study group

Intervention

Control

Children examined (n) Age in months (mean SD) Caries prevalence (n, percent) Total d3mft (n) Total d3mfs (n) d3mft in all children (mean SD) d3mfs in all children (mean SD) d3mft in children with caries (mean SD) d3mfs in children with caries (mean SD) SiC30

96 82.6 9.9 31 + (32.3) 95 140 0.99 1.81 1.46 2.59 3.06 1.95 4.52 2.63 2.97 1.99

91 82.5 10.0 30 + (33.0) 117 223 1.29 2.66 2.45 6.65 3.90 3.38 7.43 9.95 3.90 3.38

187 82.5 9.9 61 + (32.6) 212 363 1.13 2.62 1.94 5.01 3.48 2.75 5.95 7.31 3.42 2.77

262 76.1 8.2 110 + (42.0) 478 965 1.82 3.06 3.68 7.99 4.35 3.36 8.77 10.4 5.20 3.29

ns ns ns ns ns

Strengths of the study

Despite its limitations, our study also has several strengths. Its major strength is in the time span of its randomized component from well before primary teeth erupt until they start being replaced by permanent dentition. Closely, if not inherently, related is the effort of keeping the randomized groups as comparable as possible for up to 7 years. We recruited all mothers originally enrolled, irrespective of whether they had participated in the

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primary outcome assessment or not (18). The lack of statistical differences between the groups at enrolment and at follow-up, and the fact that retention rates were similar and were inuenced by the same determinants, indicates that attrition bias occurred to the same extent and for the same reasons in both arms of the trial. It provides reasonable evidence that the randomized groups, comparable at enrolment, remained comparable at follow-up. A further strength is that the SA SDS comparison group, constructed by a person not involved with the study, can be considered as representative for rst-born children living in the same areas and with similar demographic characteristics as those in the trial. This provides strong evidence that children of mothers, who had participated in the trial, suffered less severe caries and less toothache than other children, irrespective of whether their mother had received the interventions during pregnancy and the childs rst year of life. This is likely to be owing to all of these mothers being sensitized to ECC prevention (28), rather than to a tendency for trial participants to have better outcomes than nonparticipants (29, 30). Not only is the extent to which the latter inuences the generalizability of trial ndings frequently overestimated (30, 31); our comparison group consisted of people not offered participation rather than nonparticipants. While mentioned as a limitation earlier on, we believe that the use of SA SDS examinations, without knowledge of group allocation, is also a strength. It excluded observer bias and testies to the generalizability of the data to the majority of our population. Whether this would also apply to other populations requires further study.

Twetman (13). On the whole, such interventions have been very cost- or labour-intensive, relying on home visits (15, 17, 28, 32, 33) or have shown only modest effects (13, 28). Not surprisingly, and similar to our study, short-term benets are also achieved more readily (18, 34) than long-term benets. However, from a community perspective, the issue is not only how large the effect is. Equally important are: how expensive it is (32, 33), whether it is sustainable, and how much of the population it can reach (3335). Viewed from these perspectives, our intervention study certainly merits to be considered for use elsewhere.

Conclusions
Regrettably, dental care practitioners see few children before they reach school age unless there is some signicant problem. However, they do see mothers and future mothers-to-be. Providing adequate information and guidance is good practice and relatively inexpensive. In addition to the signicant impact on severe early childhood caries, demonstrated previously (18), it has benets that, to some extent, are sustained for several years. Exploring methods of engaging all new mothers in preventive strategies may help to stem early childhood caries and its ill-effects on children, families and society.

Acknowledgements
We are indebted to the Director, Dr. Andrew Chartier, and Andrew Hall of the Evaluation and Research Unit of SA SDS and to the practitioners and employees of SA SDS, who generously devoted time to this study. A vote of thanks also goes to the mothers who participated in the study. This study was supported by NHMRC Centre of Clinical Research Excellence, Adelaide, South Australia.

Community health and social implications

Unintentionally, the study conrmed that people with better education, higher income, and other determinants of higher socioeconomic status are more willing to participate in studies and in health education activities than their less fortunate counterparts (27). This element should not be overemphasized, though. The continued participation of nearly one-third of less fortunate mothers in this long-term study bears testimony to the fact that, provided they can be reached, their interest in their childs oral health is no less than that of anyone else. Several other educational programmes to prevent ECC have been reported in the literature. Those using a controlled study design for children under 3 years of age were recently reviewed by

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